Early intervention to prevent adverse child emotional and behavioural development following maternal depression in pregnancy: study protocol for a randomised controlled trial.

BACKGROUND: Substantial evidence indicates that maternal depression during pregnancy (i.e., antenatal depression) is associated not only with maternal wellbeing but also with child emotional and behavioural development. Children of antenatally depressed women are at risk of emotional and behavioural problems, including internalising problems (e.g., anxiety and depression) and externalising problems (e.g., attention problems), that may last at least to adolescence. These enduring effects also constitute an enormous economic cost. Despite the seriousness of this problem, until recently there existed very few controlled studies evaluating whether active psychological treatment for antenatal depression can prevent adverse child outcomes. Our previous pilot randomised controlled trial (RCT) exploring the effect of cognitive behavioural therapy (CBT) for antenatal depression on child outcomes showed promising results. We aim to assess whether treating antenatal depression with an evidence-based 8-week structured CBT program can prevent or ameliorate adverse child developmental outcomes at 2 years of age. METHODS: Pregnant women ≤ 30 weeks gestation diagnosed with a depressive disorder are recruited and randomised to CBT or treatment as usual (TAU). The target sample size is 230 and the primary outcome measure is the infant Internalising scale of the Child Behaviour Checklist (CBCL) at 24 months of age. Secondary infant outcome measures at 24 months are the Externalising scale of the CBCL and the motor and cognitive development subscales of the Ages & Stages Questionnaire (ASQ-3). Additional secondary outcome measures are subscales of the Revised Infant Behaviour Questionnaire (IBQ-R), ASQ-3 and the ASQ-Socio-Emotional (ASQ-SE) at 3 and 12 months of age and the quality of mother-infant interaction at 3 and 24 months. Maternal measures, including demographic data, depression diagnosis, depressive and anxiety symptoms, perceived stress and parenting stress, are collected across all time points. DISCUSSION: The trial is ongoing and recruitment was slowed due to the COVID-19 pandemic. If results suggest a beneficial effect of antenatal depression treatment on infant outcomes, the project could have repercussions for standard antenatal care, for maternal and infant health services and for preventing the intergenerational transmission of mental health disorders. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register: ACTRN12618001925235 Date Registered: 27 November 2018.

Web-based treatment for depression in pregnancy: a feasibility study of Mum2BMoodBooster.

BACKGROUND: Depression in pregnancy is prevalent, under-treated, and has serious impacts on the wellbeing of women and on child development. Internet programs can reach women who may not access traditional treatments due to distance, stigma or concern about taking medication. We adapted our online postnatal depression program, MumMoodBooster, for antenatal use. We aimed to trial feasibility, acceptability, and potential efficacy of the new Mum2BMoodBooster intervention with depressed pregnant women. METHODS: Twenty-seven pregnant women with Edinburgh Postnatal Depression Scale score > 11 used the program in a feasibility trial. Twenty-one had current diagnoses of major or minor depression on the Structured Clinical Interview for the DSM-IV. Assessment of symptoms occurred at screening/baseline, post-test (8 weeks post-enrollment), and at follow-up (3 months postpartum) using the Patient Health Questionnaire (PHQ-9) and the Depression Anxiety Stress Scales (DASS-21). RESULTS: In this feasibility trial, depression scores on both the PHQ-9 and the DASS-21, showed significant reductions representing large effects, with average symptom scores reduced by > 50%, and maintained in the 'minimal or no depression' range at 3 month follow-up. Anxiety scores also decreased significantly. Program usage was high with 74% of women visiting all six sessions. Program acceptability ratings were moderate to high. CONCLUSIONS: Findings paralleled the magnitude of symptom reductions seen in randomised trials of the postnatal MumMoodBooster program, suggesting that Mum2BMoodBooster is an effective treatment for depressed pregnant women. Effective internet therapies are likely to become increasingly important as the COVID-19 pandemic continues to make face-to-face access to health care problematic during 'lockdowns'.

Internet and Face-to-face Cognitive Behavioral Therapy for Postnatal Depression Compared With Treatment as Usual: Randomized Controlled Trial of MumMoodBooster.

BACKGROUND: Previous research has confirmed that symptoms of postnatal depression (PND) can be ameliorated through internet-delivered psychological interventions. Advantages of internet-delivered treatment include anonymity, convenience, and catering to women who are unable to access face-to-face (FTF) treatments. To date, no research has examined the efficacy of such interventions compared directly with FTF treatments in women clinically diagnosed with PND. OBJECTIVE: This study aims to compare the efficacy of one of the first web-based cognitive behavioral therapy (CBT) interventions (internet CBT+coach calls) for PND (MumMoodBooster [MMB]) with FTF-CBT in a randomized controlled trial (RCT). METHODS: In this study, 116 postnatal women with a Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition (DSM-IV) diagnosis of major or minor depression were randomized to MMB (39/116, 33.6%), FTF-CBT (39/116, 33.6%), or a treatment-as-usual (TAU) control condition (38/116, 32.8%). Diagnostic status was determined at baseline and at 21-week follow-up using the Structured Clinical Interview for the DSM-IV. Severity of anxiety and depressive symptoms was evaluated using the Depression Anxiety Stress Scales and the revised Beck Depression Inventory at baseline, 12-week follow-up (after treatment), and 21-week follow-up. RESULTS: Of the 116 participants, 107 (92.2%) had a diagnosis of major depression at baseline. Rates of remission from a major or minor depressive episode at 21 weeks in both the FTF-CBT and MMB groups were superior to that of the TAU group (56.6% and 47.7% less likely to be depressed, respectively) and they were not significantly different from each other. Although remission rates differed between TAU and FTF-CBT, growth models showed that, in terms of symptom reduction across time, the FTF-CBT treatment was not significantly better than TAU. By comparison, MMB was statistically superior to both TAU and FTF-CBT in reducing symptoms of depression, anxiety, and stress from baseline to the 21-week follow-up (large and moderate effect sizes). Thus, after 21 weeks, the average symptom scores for depression and anxiety of women receiving MMB were approximately half those of women in both the TAU and FTF-CBT groups. CONCLUSIONS: In this RCT, MMB was at least as effective as FTF-CBT in achieving remission from a diagnosed PND episode. MMB was superior to TAU and FTF-CBT in encouraging and maintaining reduction of symptom severity over the 21-week follow-up for depressed postnatal women. These findings replicate results of prior studies on MMB that showed clinically significant improvements in depressive symptoms, and they provide direct empirical support that internet-delivered treatment for depressed postnatal women is a viable alternative to FTF treatment. The generalizability of the results needs to be examined in future research, as RCTs of internet-based versus FTF treatments necessarily involve a subset of people who are willing to undertake either modality of treatment. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry (ANZCTR) ACTRN12613000881730; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364683&isReview=true.

Improving the mother-infant relationship following postnatal depression: a randomised controlled trial of a brief intervention (HUGS).

Postnatal depression (PND) disrupts the crucial mother-infant relationship on which optimal child development depends. However, few well-evaluated, brief mother-infant interaction interventions exist. This randomised controlled trial (RCT) aimed to evaluate the effect of a 4-session, group-based mother-infant interaction intervention ('HUGS'), compared to a control playgroup, both following cognitive-behavioural therapy for PND, on mother-infant relationships and early child development. It was hypothesised that dyads receiving the HUGS intervention would show larger improvements than control dyads. Mothers (n = 77; M age = 32 years) diagnosed with major or minor depressive disorder using the Structured Clinical Interview for the DSM-IV participated with their infants (<12 months). Primary outcomes were observed mother-infant interactions using the Parent Child Early Relational Assessment (ERA) and maternal parenting stress using the Parenting Stress Index (PSI). Data were collected at baseline, post-PND treatment, post-HUGS intervention and 6-month post-HUGS follow-up. Seventy-four percent of HUGS dyads attended at least half of the HUGS sessions (≥2). Significant group differences emerged at the 6-month follow-up (but were not significant immediately post-HUGS). At 6-month follow-up, HUGS dyads showed significantly improved parental positive affective involvement and verbalisation (ERA; F1, 47 = 4.96, p = .03, ηp2 = .10) and less impaired bonding (F1, 45 = 4.55, p = .04, ηp2 = .09) than control dyads. No differences were found on the PSI or on child development outcomes. Both groups improved substantially (around 30 points) on the PSI following PND treatment, so that average scores were below the clinically significant threshold when beginning HUGS and the control playgroup. Findings suggest that incorporating HUGS intervention following PND treatment is effective for improving mother-infant relationships. A longer-term follow-up and larger sample size may be needed for improved mother-infant relationships to show an impact on observable child developmental outcomes. Registered with the Australian New Zealand Clinical Trials Registry (ACTRN12612001110875).

Social Support-A Protective Factor for Depressed Perinatal Women?

Social support before and after childbirth is a possible protective factor for perinatal depression. Currently, there is a lack of longitudinal studies beyond the first year postpartum exploring the relationship of social support with depression and anxiety. Social support is also a possible protective factor for adverse child development, which is a known consequence of perinatal depression. The present study followed up a cohort of depressed women (n = 54) from a randomised controlled trial of psychological treatment for antenatal depression. We examined the trajectory of the relationships between perceived social support (Social Provisions Scale), depression (Beck Depression Inventory), and anxiety (Beck Anxiety Inventory) twice in pregnancy and twice postpartum up to two years. The influence of social support on child development and parenting-related stress was also explored. Two aspects of social support, Reassurance of Worth and Reliable Alliance, were strongly related to perinatal depression and anxiety, particularly when predicting symptoms in late pregnancy. However, the effect of postnatal depression on child development at 9 and 24 months post-birth was not mediated by social support. These results suggest the importance of adjusting current interventions for depressed perinatal women to focus on social support in late pregnancy and the first six months postpartum.

A THERAPEUTIC PLAYGROUP FOR DEPRESSED MOTHERS AND THEIR INFANTS: FEASIBILITY STUDY AND PILOT RANDOMIZED TRIAL OF COMMUNITY HUGS.

Symptoms of depression negatively impact on mother-infant relationships and child outcomes. We evaluated a novel, 10-session mother-infant therapeutic playgroup-Community HUGS (CHUGS)-which combines cognitive and experiential components through psychoeducation, play, music, and movement. Participants were mothers experiencing a range of postnatal mental health difficulties, including depression, with infants ≤12 months of age. However, the aim was not to treat maternal depression but to ameliorate associated problems in the mother-infant interaction. In the feasibility study, all participants received CHUGS. In the pilot randomized controlled trial (RCT), participants were randomized between intervention and a wait-list. Outcomes were the Parenting Stress Index (PSI; R.R. Abidin, 1995), Parenting Sense of Competency Scale (Self-Efficacy subscale; J. Gibaud-Wallston & L.P. Wandersman, 1978), and the Depression, Anxiety, Stress Scales (P.F. Lovibond & S.H. Lovibond, 1995). In the feasibility study (n = 74), PSI scores dropped on all subscales, all ps < .01. Depression, p < .001, anxiety, p = .01, stress, p = .01, and self-efficacy, p < .001, all showed improvements, as did observer-rated mother-infant interactions, p < .001. In the RCT, depression, p < .001, anxiety, p = .005, and stress, p < .001, symptoms were significantly reduced for intervention participants (n = 16), as compared to wait-list participants (n = 15). The CHUGS program had high participant satisfaction and produced improvements in self-efficacy, depression, anxiety, stress, and mother-infant interactions that supported the program's acceptability and the utility of further rollout.

Improving help-seeking for postnatal depression and anxiety: a cluster randomised controlled trial of motivational interviewing.

Low uptake of treatment by women with symptoms of postnatal depression and anxiety is consistently reported. This study examined whether a brief motivational interviewing (MI) intervention delivered by Maternal and Child Health Nurses (MCHNs) during routine emotional health assessments improves help-seeking following childbirth. In this parallel two-group cluster randomised controlled trial, MCHNs delivered a MI intervention ('PRIMER', n = 20) or Routine Care (n = 20) at women's (n = 541) postnatal consultations. The primary outcome was help-seeking over the 12 months post-birth. Other outcomes were emotional distress measured by the Edinburgh Postnatal Depression Scale, Beck Depression Inventory-Revised and Depression Anxiety Stress Scales, and barriers to help-seeking obtained by self-report via a checklist of potential barriers that was presented to women to select from if applicable. 27.4% of the sample experienced emotional distress over the 12 months post-birth. When comparing women who experienced emotional distress with those who did not, odds of seeking help were 4.0 times higher for the MI condition than Routine Care (p = .004). Of the women who sought help from a psychologist, 47.6% in the MI condition attended 6 + sessions versus 20.0% in Routine Care (numbers too small for reliable significance test). There was a non-significant trend of lower depression, anxiety and stress in the MI condition. Three risk factors for postnatal depression predicted help-seeking: antenatal anxiety (OR = 2.8, p = .002), depression history (OR = 2.5, p = .002) and self-esteem (OR = 0.7, p = .04). Common barriers to seeking help were thinking that one would or should be able to manage without help (endorsed by 11.1%). Treatment uptake for postnatal distress can be increased with MI. Training MCHNs in MI was feasible and valued. Given the devastating effects of depression, further research is needed to ascertain whether MI can improve mental health outcomes. Australian New Zealand Clinical Trials Registry (ACTRN12611000635965), 22 June 2011.

Internet Cognitive Behavioral Therapy for Women With Postnatal Depression: A Randomized Controlled Trial of MumMoodBooster.

BACKGROUND: There are few published controlled trials examining the efficacy of Internet-based treatment for postnatal depression (PND) and none that assess diagnostic status (clinical remission) as the primary outcome. This is despite the need to improve treatment uptake and accessibility because fewer than 50% of postnatally depressed women seek help, even when identified as depressed. OBJECTIVE: In a randomized controlled trial (RCT), we aimed to test the efficacy of a 6-session Internet intervention (the MumMoodBooster program, previously evaluated in a feasibility trial) in a sample of postnatal women with a clinical diagnosis of depression. The MumMoodBooster program is a cognitive behavioral therapy (CBT) intervention, is highly interactive, includes a partner website, and was supported by low-intensity telephone coaching. METHODS: This was a parallel 2-group RCT (N=43) comparing the Internet CBT treatment (n=21) to treatment as usual (n=22). At baseline and at 12 weeks after enrollment, women's diagnostic status was assessed by telephone with the Standardized Clinical Interview for DSM-IV (SCID-IV) and symptom severity with the Beck Depression Inventory (BDI-II). Depression symptoms were measured repeatedly throughout the study period with the Patient Health Questionnaire (PHQ-9). RESULTS: At the end of the study, 79% (15/19) of women who received the Internet CBT treatment no longer met diagnostic criteria for depression on the SCID-IV (these outcome data were missing for 2 intervention participants). This contrasted with only 18% (4/22) remission in the treatment as usual condition. Depression scores on the BDI-II showed a large effect favoring the intervention group (d=.83, 95% CI 0.20-1.45). Small to medium effects were found on the PHQ-9 and on measures of anxiety and stress. Adherence to the program was very good with 86% (18/21) of users completing all sessions; satisfaction with the program was rated 3.1 out of 4 on average. CONCLUSIONS: Our results suggest that our Internet CBT program, MumMoodBooster, is an effective treatment option for women clinically diagnosed with PND. This is one of only two controlled evaluations of specialized online psychological treatment among women clinically diagnosed with PND. MumMoodBooster appears to be a feasible, effective treatment option, which is potentially accessible to large numbers of women in metropolitan, rural, and remote areas. Future work might be focused profitably on establishing comparability with face-to-face treatments and purely self-guided delivery. We have commenced a larger RCT comparing MumMoodBooster with face-to-face CBT. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000113752; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363561 (Archived by WebCite® at http://www.webcitation.org/6f64kuyLf).

Feasibility study and pilot randomised trial of an antenatal depression treatment with infant follow-up.

Substantial evidence links antenatal depression, anxiety and stress with negative effects on foetal development, resulting in enduring problems in child development. Despite this, there is a paucity of research on intervention programmes designed to address depression and anxiety, and none that include infant outcomes. We aimed to evaluate the efficacy of a brief treatment for maternal depression and anxiety in pregnancy in a sample of women with a diagnosed depressive disorder. We developed a cognitive behavioural therapy treatment for antenatal depression and anxiety and evaluated it in a feasibility trial. This was followed by a pilot randomised controlled trial (RCT) which collected data on the efficacy of the brief intervention and follow-up data on infants. The feasibility study (n = 25) yielded promising results for adherence, acceptability and improvements in depression and anxiety (Beck Depression Inventory and Beck Anxiety Inventory). The RCT (n = 54) again showed excellent adherence and acceptability and supported the efficacy of the treatment. Strong reductions in anxiety were observed during pregnancy, and improvements in depression were maintained at 9 months representing a moderately large effect size. Nine-month infant outcomes showed several medium to large effects favouring the intervention in domains including problem solving, self-regulation and stress reactivity, which were independent of maternal postnatal mood. Treating severe depression and anxiety during pregnancy with a brief cognitive behavioural therapy (CBT) intervention appears feasible and worthwhile. To reliably detect clinically meaningful effects on infant outcomes, larger RCTs are likely to be required.

Early intervention to protect the mother-infant relationship following postnatal depression: study protocol for a randomised controlled trial.

BACKGROUND: At least 13% of mothers experience depression in the first postnatal year, with accompanying feelings of despair and a range of debilitating symptoms. Serious sequelae include disturbances in the mother-infant relationship and poor long-term cognitive and behavioural outcomes for the child. Surprisingly, treatment of maternal symptoms of postnatal depression does not improve the mother-infant relationship for a majority of women. Targeted interventions to improve the mother-infant relationship following postnatal depression are scarce and, of those that exist, the majority are not evaluated in randomised controlled trials. This study aims to evaluate a brief targeted mother-infant intervention, to follow cognitive behavioural therapy treatment of postnatal depression, which has the potential to improve developmental outcomes of children of depressed mothers. METHODS/DESIGN: The proposed study is a two-arm randomised controlled trial with follow-up to 6 months. One hundred participants will be recruited via referrals from health professionals including maternal and child health nurses and general practitioners, as well as self-referrals from women who have seen promotional materials for the study. Women who meet inclusion criteria (infant aged <12 months, women 18+ years of age) will complete the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-IV-TR Axis I Disorders. Those with a clinical diagnosis of current major or minor depressive disorder and who do not meet exclusion criteria (that is, currently receiving treatment for depression, significant difficulty with English, medium to high suicide risk, current self-harm, current substance abuse, current post-traumatic stress disorder, current manic/hypomanic episode or psychotic symptoms) will be randomised to receive either a 4-session mother-infant intervention (HUGS: Happiness Understanding Giving and Sharing) or a 4-session attention placebo playgroup (Playtime) following a 12-session postnatal depression group treatment programme. Primary outcome measures are the Parenting Stress Index (self-report measure) and the Parent-child Early Relational Assessment (observational measure coded by a blinded observer). Measurements are taken at baseline, after the postnatal depression programme, post-HUGS/Playtime, and at 6 months post-HUGS/Playtime. DISCUSSION: This research addresses the need for specific treatment for mother-infant interactional difficulties following postnatal depression. There is a need to investigate interventions in randomised trials to prevent detrimental effects on child development and make available evidence-based treatments. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register: ACTRN12612001110875. Date Registered: 17 October 2012.

Guidelines for evaluation of patients at risk for inherited breast and ovarian cancer: recommendations of the Department of Defense Familial Breast/Ovarian Cancer Research Project.

Patients at high risk for inherited breast and/or ovarian cancer are frequently encountered in all medical specialties. Department of Defense, Health Affairs funding as part of the Breast Cancer Education and Awareness Program was used to develop a comprehensive program for the identification, counseling, genetic testing, and long-term follow-up of such high-risk patients. This article reports the recommendations for high-risk patient management based on 4 years of evaluation and care, including discussions of the approach to counseling, indications for genetic testing, post-testing counseling, patient surveillance with examination, imagining, and laboratory testing, and suggested options for surgical and chemoprophylaxis as well as lifestyle modifications.

Diagnostic criteria for testing for BRCA1 and BRCA2: the experience of the Department of Defense Familial Breast/Ovarian Cancer Research Project.

The Department of Defense Familial Breast/Ovarian Cancer Research Project has offered genetic counseling and testing for BRCA1 and BRCA2 on a research basis to patients meeting specific diagnostic criteria, with risk for BRCA1 and BRCA2 mutations calculated based on the Couch model. In 2.5 years, 250 patients were evaluated and 101 patients met criteria requirements, including 33 who met criteria in more than one category. Ninety patients elected to undergo DNA testing. In this group of 90 patients, 14 mutations (15.5%) and 16 unclassified variants (17.7%) were identified. The most common inclusion criteria were onset of breast/ovarian cancer before age 45 years (n = 32) and onset of breast/ovarian cancer before age 45 years with strong family history (n = 21). However, when number of mutations and unclassified variants found were compared separately across all diagnostic criteria (including those of more than one capacity) using the chi 2 statistic, no significant differences were seen among the categories to suggest that one criterion was more predictive of mutations or variants than another. Couch risk values for patients with mutations showed a mean of 14% and ranged from 3.2 to 43.5% (range for all patients, 1.2-69.7%). These findings emphasize the importance of using multiple diagnostic criteria and suggest that a Couch risk value of > 3% may be useful in selecting patients for testing. The data also underscore the necessity of genetic counseling in the testing process, particularly given the large number of unclassified variants diagnosed and their uncertain status for disease predisposition.